EIA MONOCLONAL TOTAL IGE KIT

EIA MONOCLONAL TOTAL IGE KIT is an FDA 510(k)-cleared medical device (K860033) manufactured by Diagnostic Products Corp.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 6, 1986. Regulation: 8.